Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-11-04

Brief Summary

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Recent studies have shown that deep anesthesia is associated with poor outcome. There is still lack of randomized controlled trials with large sample size on the effect of depth of anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The investigators are performing a randomized and parallel group trial. The aim of the study is to determine whether there is a causal relationship between the depth of anesthesia and postoperative clinical outcome in patients undergoing supratentorial tumor surgery.

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Detailed Description

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Conditions

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Anesthesia, Brain Tumor, Supratentorial,Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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The deep anesthesia group

Group Type OTHER

Bispectral index will be targeted at 35

Intervention Type OTHER

The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.

The light anesthesia group

Group Type OTHER

Bispectral index will be targeted at 50

Intervention Type OTHER

The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.

Interventions

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Bispectral index will be targeted at 50

The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.

Intervention Type OTHER

Bispectral index will be targeted at 35

The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Patients who undergo emergency or awake craniotomy surgery, or unable to present the written consent will be excluded from the trial. The patients whose incision site conflicts with the placement of BIS electrode on the frontal and temporal lobe will also be excluded from the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No